- Device
- Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Cool Path Duo, MediGuide Enabled, and Safi
- Applicant
- ABBOTT MEDICAL
- PMA number
- P110016
- Supplement
- S067
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2020-04-24
- Decision code
- APPR
- Date received
- 2020-02-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for new pouch materials, pouch seal strength, and pouch sealer changes.